相关临床试验
5
4 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
4
80.0%
已完成
1
20.0%
- Sonoma Biotherapeutics has appointed Stephen Dilly, MBBS, PhD, as its new President and CEO, replacing co-founder Jeff Bluestone who transitions to an advisory role. - The leadership change follows positive interim safety and efficacy results from the company's first-in-human study of SBT-77-7101 in patients with refractory rheumatoid arthritis. - Dr. Dilly brings nearly 40 years of biopharmaceutical experience and has been associated with the development, approval and launch of more than 25 marketed drugs. - The company is developing engineered regulatory T cell therapies for autoimmune and inflammatory diseases, with a collaboration pipeline including Regeneron.
- Aravax has appointed Louise Peacock as Chief Regulatory and Quality Officer, bringing over 35 years of pharmaceutical industry experience to the company's Oxford, UK operations. - Peacock previously contributed to the approval of Palforzia®, the first and only FDA-approved oral immunotherapy for peanut allergy, during her tenure at Aimmune Therapeutics. - The appointment positions Aravax to advance its lead candidate PVX108, currently in Phase 2 trials, toward Phase 3 development for peanut allergy treatment. - PVX108 represents a next-generation immunotherapy approach using engineered peptides designed to retrain the immune system without risking treatment-induced anaphylaxis.
- The FDA has expanded the approval of Palforzia to include children aged 1 through 3 years with a confirmed peanut allergy. - Palforzia is designed to mitigate allergic reactions, including anaphylaxis, that may occur due to accidental peanut exposure. - The drug has been approved since January 2020 for individuals aged 4 through 17 years with a confirmed peanut allergy. - Patients taking Palforzia must continue to avoid peanuts in their diets, and a Risk Evaluation and Mitigation Strategy (REMS) is in place.
• Nestlé Health Science has sold its peanut allergy treatment Palforzia to Stallergenes Greer, just three years after acquiring Aimmune Therapeutics for $2.6 billion. • Despite being the first FDA-approved therapy for peanut allergy in children aged 4-17, Palforzia's market performance remained modest due to complex administration requirements and clinical monitoring challenges. • The acquisition positions Stallergenes Greer as the first company to offer both respiratory and food allergy treatments, while Nestlé retains future milestone payments and royalty rights.
